Regulatory position Regulatory concerns
Current Regulatory Initiative
Perception of advantages Perception of concern
Any comments on PK/PD in the current guidelines?
Proposal for guidance on PK-PD during drug development
Proposal for guidance on PK-PD during clinical drug development
Validate the pre-clinical PK/PD concept in phase I/II trials (before phase III trials)
Confirm the concept in confirmatory clinical endpoint studies
End product:Improved dose recommendation to prescribing doctors (SPC section 4.2, 5.1.)
To further substantiate clinical endpoint data?
To further substantiate clinical endpoint data? To allow extrapolation to other populations
To further substantiate clinical endpoint data? To use PK/PD data to increase assay sensitivity
To use PK/PD data to increase assay sensitivity
Do you agree that
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